A Clinical Trial of Metformin to Decrease Glucocorticoids Side Effects in Patients With Autoimmune Uveitis

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This project is designed to evaluating the use of combination therapy of glucocorticoid and metformin to decrease glucocorticoid side effects in participants with autoimmune uveitis.This study also aims to evaluate the anti-inflammatory and immunosuppressive effects of combination therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University
• Collaborators: Peking Union Medical College Hospital; Peking Union Medical College Hospital, Peking University First Hospital and Zhongshan Ophthalmic Center， Sun Yat-sen University; Peking University First Hospital; Zhongshan Ophthalmic Center, Sun Yat-sen University
• Treatments: Glucocorticoids; Metformin

Criteria

Inclusion Criteria:

1. Attending Tianjin Medical University Eye Hospital, ophthalmology department of Peking Union Medical College Hospital, ophthalmology department of Peking University First Hospital and Zhongshan Ophthalmic Center Sun Yat-sen University from January 2018 to January 2022.

2. Chronic and non-infectious autoimmune uveitis with systemic glucocorticoids treatment (Initiation dosage ≥ 1 mg/kg/d or ≥ 50 mg/d).

3. FBG < 6.1 mmol/L, HbAlc<6.O%, TC <5.2 mmol/L(200 mg／d1) and TG <1.7 mmol/L(150 mg／dl).

4. All genders, age ≥ 18 years old.

5. Ready for systemic glucocorticoids treatment.

6. Willing to follow all study requirements and sign the informed consent.

7. Without history of cancer and serious systemic diseases.

Exclusion Criteria:

1. Participate in other clinical trials within the preceding one years

2. Planning ophthalmologic surgery over the next three months.

3. With other sight-threatening diseases except cataract, such as glaucoma, diabetic retinopathy, retinal detachment, and so on.

4. Taking or will take immunosuppressants which affecting glycometabolism and lipid metabolism except methotrexate and azathioprine.

5. Any known history of a serious infection (e.g., HIV, hepatitis, pneumonia, syphilis or tuberculosis).

6. Any known history of diabetes mellitus, severe hepatic, renal or heart disease.

7. Any known history of drug addiction, drug abuse and malignant tumor.

8. Presence of a transplanted solid organ.

9. Pregnant women and nursing mothers.

10. Any known history of mental disorders.